2024-518643-38-00招募中2 期
Adipose-derived mesenchymal stem cells as local treatment of ulcerative colitis
Region Midtjylland1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年11月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Reduced inflammatory activity assessed with endoscopic Mayoscore 14 days after treatment with injection of allogeneic adipose-derived mesenchymal stem cells.
研究概览
简要总结
To investigate treatment with injection of allogeneic adipose-derived mesenchymal stem cells locally in the mucosa of patients with ulcerative colitis (UC) reduces the degree of mucosal inflammation and intestinal symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized
- 主要目的
- Adipose-derived mesenchymal stem cells as local treatment of ulcerative colitis
- 盲法
- Double (Analyst, Subject, Monitor, Investigator, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Known ulcerative colitis with spread limited to the left side of the colon
- •Mild-moderate activity in UC assessed by complete Mayoscore > 2 and < 10
- •Speaks and understands Danish
- •Fully informed consent
排除标准
- •Severe disease activity assessed on the Mayoscore (score > 10)
- •Acute severe colitis according to the Truelove-Witt criteria
- •Disease spread proximal to the left flexure (extensive colitis)
- •Active malignant disease
- •Pregnancy (checked with pregnancy test (urine HCG), if fertile woman)
- •Smoker (defined as smoking cessation < 12 weeks)
- •People allergic to penicillin (the final product contains traces of penicillin)
- •Fertile women who do not use very safe contraception (defined as birth control pills, IUDs or sexual abstinence) or are sterilized
结局指标
主要结局
Reduced inflammatory activity assessed with endoscopic Mayoscore 14 days after treatment with injection of allogeneic adipose-derived mesenchymal stem cells.
Reduced inflammatory activity assessed with endoscopic Mayoscore 14 days after treatment with injection of allogeneic adipose-derived mesenchymal stem cells.
次要结局
- Demonstrate differences between the ability of mesenchymal stem cells from different donors to immunomodulation using potency assays.
- Reduced inflammatory activity assessed with endoscopic Mayoscore 4, 7, 14 and 30 days after treatment.
- Improvement in histological grading of inflammation in tissue samples day 4, 7, 14 and 30 after treatment.
- Improvement in symptoms 4, 7, 14 and 30 days after treatment assessed by complete Mayoscore
- Complications/adverse events during the treatment in relation to dose seeking
- Demonstrate the formation or absence of HLA antibodies, corresponding to the donor's HLA type, as a result of the treatment.
研究者
Klaus Krogh
Scientific
Region Midtjylland
研究点 (1)
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